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China PEACE-Prospective AMI Study

NCT ID: NCT01624909

Last Updated: 2015-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-07-31

Brief Summary

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Coronary heart disease (CHD) and heart attacks pose a serious health risk to men and women, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety and efficacy of treatment for AMI is limited. By consecutively recruiting AMI patients in 40 hospitals of different levels, this study will examine various real-life factors, that may affect patients recovery after a heart attack. Practical guidelines and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Detailed Description

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Cardiovascular disease (CVD) is a major concern in public health globally, as well as in China, and AMI is one of the leading causes of mortality and morbidity. Remarkable variations of resources available and health system performance have been noted, however little information is available about how evidence-based therapies are incorporated appropriately into routine clinical practice in China. In addition, basic data and evidence about safety, efficacy, and effectiveness of treatment for AMI during long-term recovery is limited. Practical and applied knowledge from large unselected population is needed to guide practice and policy for quality improvement and cost reduction.

This study will enroll patients with a confirmed diagnosis of AMI consecutively in 20 tertiary hospitals and 20 secondary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine various real-life factors that may affect patients recovery after a heart attack, including patients' characteristics and treatment measures. Practical guidelines, quality evaluative system, and risk model for AMI patients will be established based on the findings, to improve patients outcomes in future finally.

Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients with acute myocardial infarction according to positive cardiac biomarkers (Troponin I/T, CK-MB or CK≥ local laboratory upper limit of normal values within 24 hours after initial presentation, and at least one of the following two supporting evidence of ischemia (ischemic symptoms occurring within 24 hours before admission or up to 72 hours for STEMI; ECG changes indicative of new ischemia).

Exclusion Criteria

* Previously enrolled in the PEACE study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, China

OTHER_GOV

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lixin Jiang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Diseases

Harlan M Krumholz, M.D., S.M.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Li J, Dharmarajan K, Bai X, Masoudi FA, Spertus JA, Li X, Zheng X, Zhang H, Yan X, Dreyer RP, Krumholz HM. Thirty-Day Hospital Readmission After Acute Myocardial Infarction in China. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005628. doi: 10.1161/CIRCOUTCOMES.119.005628.

Reference Type DERIVED
PMID: 31092023 (View on PubMed)

Shang P, Liu GG, Zheng X, Ho PM, Hu S, Li J, Jiang Z, Li X, Bai X, Gao Y, Xing C, Wang Y, Normand SL, Krumholz HM. Association Between Medication Adherence and 1-Year Major Cardiovascular Adverse Events After Acute Myocardial Infarction in China. J Am Heart Assoc. 2019 May 7;8(9):e011793. doi: 10.1161/JAHA.118.011793.

Reference Type DERIVED
PMID: 31057004 (View on PubMed)

Huo X, Khera R, Zhang L, Herrin J, Bai X, Wang Q, Lu Y, Nasir K, Hu S, Li J, Li X, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Education level and outcomes after acute myocardial infarction in China. Heart. 2019 Jun;105(12):946-952. doi: 10.1136/heartjnl-2018-313752. Epub 2019 Jan 19.

Reference Type DERIVED
PMID: 30661037 (View on PubMed)

Jiang Z, Dreyer RP, Spertus JA, Masoudi FA, Li J, Zheng X, Li X, Wu C, Bai X, Hu S, Wang Y, Krumholz HM, Chen H; China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Collaborative Group. Factors Associated With Return to Work After Acute Myocardial Infarction in China. JAMA Netw Open. 2018 Nov 2;1(7):e184831. doi: 10.1001/jamanetworkopen.2018.4831.

Reference Type DERIVED
PMID: 30646375 (View on PubMed)

Guan W, Venkatesh AK, Bai X, Xuan S, Li J, Li X, Zhang H, Zheng X, Masoudi FA, Spertus JA, Krumholz HM, Jiang L. Time to hospital arrival among patients with acute myocardial infarction in China: a report from China PEACE prospective study. Eur Heart J Qual Care Clin Outcomes. 2019 Jan 1;5(1):63-71. doi: 10.1093/ehjqcco/qcy022.

Reference Type DERIVED
PMID: 29878087 (View on PubMed)

Qi Y, Wang W, Zhang K, An S, Wang S, Zheng J, Tang YD. Development and validation of Women Acute Myocardial Infarction in-Hospital Mortality Score (WAMI Score). Int J Cardiol. 2018 May 15;259:31-39. doi: 10.1016/j.ijcard.2017.12.010.

Reference Type DERIVED
PMID: 29579607 (View on PubMed)

Other Identifiers

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WSGY-201202025-3

Identifier Type: -

Identifier Source: org_study_id